RecruitingNCT05336877

Aveir VR Coverage With Evidence Development Post-Approval Study

Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study


Sponsor

Abbott Medical Devices

Enrollment

8,744 participants

Start Date

Jun 21, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This post-approval study compares the real-world safety and effectiveness of the Aveir VR leadless pacemaker — a tiny pacemaker implanted directly in the heart without leads (wires) — versus traditional single-chamber pacemakers. The study uses Medicare claims data to track long-term outcomes. You may be eligible if: - You are a Medicare beneficiary - You received an Aveir VR leadless pacemaker or a standard single-chamber ventricular pacemaker on or after the study start date in any US location You may NOT be eligible if: - There are no specific exclusion criteria for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAveir VR Leadless Pacemaker System

This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study.

DEVICESingle-Chamber Transvenous Pacemaker

This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.


Locations(1)

Abbott

Sylmar, California, United States

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NCT05336877


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